Application 021894

Type: NDA
Sponsor: VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XENAZINE	TETRABENAZINE	TABLET;ORAL	12.5MG	Yes	No
002	XENAZINE	TETRABENAZINE	TABLET;ORAL	25MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021894-001	XENAZINE	TETRABENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15
N021894-002	XENAZINE	TETRABENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021894-001	AB
N021894-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021894-001	XENAZINE	12.5MG	TABLET / ORAL	AB	RLD	2008-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021894-002	XENAZINE	25MG	TABLET / ORAL	AB	RLD, RS	2008-08-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021894-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021894-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021894-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021894-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021894-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021894-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021894-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021894-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021894-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021894-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021894-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021894-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021894-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021894-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021894-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021894-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021894-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021894-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021894-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021894-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021894-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021894-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021894-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021894-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021894-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021894-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021894-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021894-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021894-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021894-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021894-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021894-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021894-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021894-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021894-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021894-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021894-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021894-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021894-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021894-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tetrabenazine	TETRABENAZINE	Oceanside Pharmaceuticals	5867189c-17bd-4e70-a079-c4730f9950d1	2019-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021894 application number: NDA021894 ndc (product): 68682-422 ndc (product): 68682-421
Xenazine	TETRABENAZINE	Lundbeck Pharmaceuticals LLC	ac768bab-8afa-4446-bc7f-caeeffec0cda	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021894 application number: NDA021894 ndc (product): 67386-421 ndc (product): 67386-422

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67386-421	Xenazine	tetrabenazine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-421	Xenazine	tetrabenazine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-421	Xenazine	tetrabenazine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-421	Xenazine	tetrabenazine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-421	Xenazine	tetrabenazine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-422	Xenazine	tetrabenazine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-422	Xenazine	tetrabenazine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-422	Xenazine	tetrabenazine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-422	Xenazine	tetrabenazine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-422	Xenazine	tetrabenazine	Lundbeck Pharmaceuticals LLC	NDA	Current
68682-421	tetrabenazine	tetrabenazine	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-421	tetrabenazine	tetrabenazine	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-422	tetrabenazine	tetrabenazine	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-422	tetrabenazine	tetrabenazine	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49816	SUPPL	2017-09-21
49815	SUPPL	2017-09-21
49802	SUPPL	2017-09-19
6402	SUPPL	2015-08-27
28800	SUPPL	2015-06-04
16531	SUPPL	2015-06-04
28799	SUPPL	2013-08-05
6401	SUPPL	2012-08-27
28798	SUPPL	2011-07-07
16530	SUPPL	2011-07-07
6400	SUPPL	2011-05-06
37837	SUPPL	2011-05-05
28797	SUPPL	2010-01-27
28796	SUPPL	2010-01-27
24225	ORIG	2008-10-09
21861	ORIG	2008-10-09
37836	ORIG	2008-08-26
6399	ORIG	2008-08-21